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临床试验/NCT06870370
NCT06870370尚未招募3 期

Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月20日最近更新:
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Mortality

研究概览

简要总结

The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury

详细描述

The primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia.

Severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality .

β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. In the Intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. This hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . It occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury .

A Non-Selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18and 65 years old
  • Patients who have Severe traumatic brain injury
  • Glascow outcome scale ≤ 8

排除标准

  • Patients have pre-existing heart disease.
  • If there are contraindications to β blocker.
  • penetrating traumatic brain injury.
  • pre-injury brain dysfunction.
  • β-blocker or α2-agonist use before trauma.

研究组 & 干预措施

Propranolol group

Experimental

This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days.

干预措施: propranolol (Drug)

normal saline IV group

Placebo Comparator

This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days

干预措施: normal saline IV (Drug)

结局指标

主要结局

Mortality

时间窗: 7 days

Mortality in severe traumatic brain injury with usage of β blocker

次要结局

  • Glascow outcome scale extended(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huda Talaat Ibrahim Elkallaf

Resident of Emergency Medicine and Traumatology

Tanta University

研究点 (1)

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